US Quality Assurance Head - GMP & Regulatory Leader

GenScript; Pennington (NJ); On-site; USD 190,000 - 250,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401(k) with company match

Paid parental leave

Extensive PTO (vacation/personal/sick/

Floating holidays

Job summary

GenScript USA Inc./ProBio Inc. is seeking a Head of Quality Assurance to lead the US QA organization and ensure compliance with FDA, EMA, ICH and GMP across all CDMO manufacturing operations.

The role collaborates with cross‑functional teams to support growth and successful customer project delivery. Responsibilities include developing and maintaining the QMS, managing deviations, CAPA, change control, document control, and product release oversight, while preparing for regulatory inspections

Qualifications

• Bachelor's degree in Life Sciences or related discipline.
• 10+ years in quality leadership in biotech/CDMO.
• Experience with QMS, QA operations, risk management.
• Knowledge of FDA/EMA/ICH and GMP regs.
• Experience leading regulatory inspections and audits.
• Strong leadership and stakeholder management.

Responsibilities

• Lead US QA org to ensure FDA/EMA/ICH/GMP compliance.
• Develop and improve QMS, deviations, CAPA, change control, doc control.
• Provide QA oversight for GMP manufacturing and process development.
• Ensure readiness for inspections and audits.
• Lead customer quality activities and audits.
• Partner across functions to deliver CDMO projects with quality.
• Drive continuous improvement in quality systems.
• Coach and develop QA team.
• Monitor quality metrics and manage risk.

Skills

Leadership

Quality Assurance

Regulatory experience

Quality Management Systems

Cross-functional collaboration

Quality metrics

Education

Bachelor's degree in Life Sciences or related

Advanced degree preferred (MS/PhD)

Tools

QMS software

GMP knowledge

Job description

GenScript USA Inc./ProBio Inc. is seeking a Head of Quality Assurance to lead the US QA organization and ensure compliance with FDA, EMA, ICH and GMP across all CDMO manufacturing operations.

The role collaborates with cross‑functional teams to support growth and successful customer project delivery. Responsibilities include developing and maintaining the QMS, managing deviations, CAPA, change control, document control, and product release oversight, while preparing for regulatory inspections